By Paula Sanders

Law360 (January 26, 2021, 5:28 PM EST) --

Paula Sanders

Long-term care facilities have shouldered some of the most difficult burdens of the COVID-19 pandemic, housing and caring for patients who are among those most at risk not just for infection, but ongoing symptoms and challenges associated with the disease.

While facilities like skilled nursing facilities, continuing care retirement facilities, personal care homes and other residential facilities answered the call to protect their residents and staff from COVID-19, the impact of the disease was immediately felt early and often in the pandemic.

Facilities have been under increased survey scrutiny since the start of the COVID-19 pandemic, with regulators at the federal, state and local levels all seeming to agree that somehow skilled nursing facilities and other congregate facilities should be better able to control outbreaks and infections.

All of this against a backdrop of inconsistent government guidance and support, ranging from confusing and contradictory instructions about mask wearing and cohorting, to failing to provide adequate supplies of personal protective equipment, and most recently in Pennsylvania, failing to ensure adequate provisions for testing and inoculations.

Worse, these facilities continue to battle not just continued infections amongst staff and residents, but ongoing health impacts for those who successfully recover, even as vaccines make their way into these settings.

The Centers for Medicare and Medicaid Services perceives a "heightened threat to resident health and safety for even low-level isolated infection control citations (such as proper hand washing and use of PPE)."

Despite well-documented challenges resulting from government missteps, CMS nonetheless believes expanded enforcement regarding infection control will improve accountability and sustained compliance with fundamental health and safety protocols. On June 1, 2020, CMS issued new requirements for on-site focused infection control surveys, which was revised and updated on Jan. 4, 2021.

Skilled nursing facilities must be prepared to respond with detailed documentation and continued vigilance in their efforts to combat COVID-19.

New Triggers for Focused Infection Control Surveys

States must conduct annual focused infection control surveys at 20% of all skilled nursing facilities beginning Oct. 1, 2020. Almost all these focused infection control surveys must be standalone surveys not associated with a recertification survey, although focused infection control surveys triggered by meeting the criteria below may count toward meeting the 20% requirement.

Under the new CMS guidance, states must conduct focused infection control surveys at skilled nursing facilities within 3-5 days of identification of any of the following factors that may place residents' health and safety at risk, including:

• Three or more new COVID-19 suspected and confirmed cases since the last COVID-19 report from the National Healthcare Safety Network;

• One confirmed resident case in a facility that was previously COVID-19 free;

• Multiple weeks with new COVID-19 cases;

• Low staffing;

• Selection as a special focus facility;

• Concerns related to conducting outbreak testing per CMS requirements; and

• Allegations or complaints which pose a risk for harm or immediate jeopardy to the health or safety of residents which are related to certain areas, such as abuse or quality of care (e.g., pressure ulcers, weight loss, depression, decline in functioning).

Surveyors are also being told to "be alert to, and investigate any concerns related to residents who have had a significant decline in their condition (e.g., weight loss, mobility) during the PHE [Public Health Emergency]."[1]

CMS Links Expected Decline in Clinical Conditions to Quality of Care

CMS' direction to look for quality of care issues related to pressure ulcers, weight loss, depression and decline in functioning is troubling because these are known effects of COVID-19 infection in the elderly who typically lose their appetite as well as their senses of taste and smell thus often making weight loss unavoidable.

Likewise, skin failure is often not preventable if there is unavoidable weight loss. Depression and decline in functioning may also be directly related to COVID-19, particularly in facilities that have been required by the government to restrict visitation and communal dining and other social activities.

COVID-19 related weight loss and deconditioning is practically inevitable, and the survey system should be more adept at recognizing these circumstances. An anticipated clinical decline should not be cited as per se evidence that a facility was at fault.

There should be some flexibility within the survey rubric to recognize when facilities in the middle of a COVID-19 outbreak are still providing care, even if there is a paucity of documentation; facilities that are operating all hands on deck may simply not have the time to document the care that they are providing. Nonetheless, facilities should be working with their clinical staff and social workers to improve documentation in these areas.

Frequency of Focused Infection Control Surveys

Prior to the issuance of the revised quality safety and order memo, some skilled nursing facilities were having focused infection control surveys several times a month.

Perhaps recognizing the burden these surveys put upon facilities that are in the middle of a COVID-19 outbreak, CMS has now advised that facilities that trigger a focused infection control survey do not need to be resurveyed if a focused infection control survey was conducted within the previous three weeks.

However, if a facility triggers any of the criteria in the fourth week after a focused infection control survey was conducted, an additional focused infection control survey must be conducted within 3-5 days.

No Carrots, Only a Bigger Stick: Enhanced Enforcement Remedies for Infection Control Deficiencies

CMS has developed a new enforcement rubric for infection control deficiencies at F880 that includes higher civil money penalties, directed plans of correction, discretionary denials of payment for new admissions if the facility does not regain substantial compliance within specified time periods depending on the scope and severity of the current violation and the facility's prior infection control history over the past two years.

The table below illustrates the new sanction protocol.

Scope and Severity	No Infection Control Deficiencies in Past Year	Infection Control Deficiencies Cited Once in Past Year	Infection Control Deficiencies Cited Twice or More in Past Two Years	Current Noncompliance With Infection Control Deficiencies Regardless of Past History
Not Widespread Potential For Harm	Directed plan of correction	Directed plan of correction; Discretionary denial of payment for new admissions with 45 days to demonstrate compliance; and Per instance civil money penalty up to $5000 at state/CMS discretion.	Directed plan of correction; Discretionary denial of payment for new admissions, 30 days to demonstrate compliance with infection control deficiencies; and $15,000 per instance civil money penalty (or per day civil money penalty, as long as the total amount exceeds $15,000).
Widespread	Directed plan of correction; and Discretionary denial of payment for new admissions with 45 days to demonstrate compliance.	Directed plan of correction; Discretionary denial of payment for new admissions with 45 days to demonstrate compliance; and $10,000 per instance civil money penalty.
Actual Harm				Directed plan of correction; Discretionary denial of payment for new admissions with 30 days to demonstrate compliance; and Civil money penalty imposed at highest amount option in the civil money penalty analytic tool.
Immediate Jeopardy				Mandatory remedies of temporary manager or termination; Directed plan of correction; Discretionary denial of payment for new admissions, 15 days to demonstrate compliance; and Civil money penalty imposed at highest amount option in the civil money penalty analytic tool.

The deterrent impact of these enhanced sanctions is questionable. Facilities and their staff are trying to do the right thing in almost all circumstances, and perceived failures are often more likely the result of poor documentation, not poor quality of care. Given the cumulative effects of even low-level deficiencies related to infection control, facilities should consider challenging citations through the informal dispute resolution process whenever feasible.

Additional Infection Control Regulations and Requirements

On Sept. 2, 2020, CMS published an interim final rule with comment that created new regulations on testing requirements, reporting, and sanctions related to COVID-19. The regulations were effective upon publication and most facilities are aware of these new requirements. But because many facilities may have not yet been cited for deficient practices, they may not fully appreciate the scope of the new penalties.

For example, in addition to the enhanced penalties for noncompliance with F880, which is concerned with infection control, skilled nursing facilities are now being sanctioned at F882 if they have not designated one or more persons to serve as their infection control preventionist.

If they are late reporting to the National Healthcare Safety Network, even if there are problems with the NHSN website, facilities are being fined at F884 at the rate of $1,000 in civil money penalties for the first week, increasing by $500 each subsequent failure up to $6,500 per violation.

Facilities should challenge these by filing an independent informal dispute resolution directly with CMS. Failure to inform residents, representatives and families about COVID-19 issues will result in a deficiency at F885, and failure to test as required will be cited at F886. Surveyors have been instructed not to cite testing failures if the facility can provide documentation of attempts to perform and/or obtain testing assistance.

Facilities should pay careful attention to alerts and other messages that are released periodically by the Pennsylvania Departments of Health, Human Services and Aging, as well as from CMS, the Centers for Disease Control and Prevention, and NHSN as these may help to defend against civil and administrative claims. Facilities should also work with staff to improve documentation habits, including taking screen shots of attempts to log in to various reporting sites.

Skilled nursing facilities have been nothing short of heroic in their efforts battling COVID-19 and have looked for full support and partnership from regulators during the pandemic. While they hoped that collaborative efforts would have yielded more realistic survey scrutiny, they will respond as they have throughout the siege, with the health and well-being of their residents and staff as their primary focus.

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Paula Sanders is a principal and co-chair of the health care practice group at Post & Schell PC.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] QSO-20-31-All at 4.

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